Select Page

IEC 60601-2-45 Mammographic X-Ray Equipment and Mammographic Stereotactic Devices Testing

Medical electrical equipment – Part 2-45: basic safety and essential performance of mammographic X-ray equipment and mammomagraphic stereotactic devices

IEC 60601-2-45 Scope:

IEC 60601 2 45 and EN 60601 2 45 testing applies to the basic safety and essential performance of mammographic X-ray equipment, including equipment for mammographic tomosynthesis, and mammographic stereotactic devices, hereafter also referred to as medical electronic equipment.

NOTE 1 This includes mammographic X-ray equipment using integrated digital X-ray image receptors or integrated storage phosphor subsystems.

Excluded from the scope of IEC 60601 2 45 are:

  • Reconstructive tomography modes of operation other than mammographic tomosynthesis;
  • CT scanners covered by IEC 60601-2-44;
  • Diagnostic consoles;
  • Picture archiving and communication systems (PACS);
  • Non-integrated storage phosphor readers;
  • Hard copy cameras;
  • Films, screens and cassettes;
  • Computer aided detection (CAD);
  • Devices for performing core biopsy and other biopsy instruments;
  • Modes of operation intended to demonstrate local contrast medium uptake (contrast enhanced digital mammography);

NOTE 2 IEC 60601-2-7:1998 and IEC 60601-2-32 are not part of the 3rd edition scheme for mammographic X-ray equipment and mammographic stereotactic devices.

Keystone Compliance assists manufacturers with IEC 60601-2-45 and EN 60601-2-45 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-45 test lab needs.